Topic:

Regulatory

Latest Headlines

Latest Headlines

In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial

One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.

Syngene IPO by India's Biocon reaches top of range with no GVK, Quest blowback

India's Biocon easily reached the top end of its offer range for an initial public offering of shares in CRO Syngene, a source said, adding that recent reports of troubles at other Indian companies in the sector had no impact on demand.

India drugs watchdog to look at feasibility of online drug sales

The Drugs Controller General of India has moved to create a subcommittee to study the feasibility of online drug sales even in the face of strong opposition from brick-and-mortar pharmacies and as restrictions on such sales are routinely flouted, DNA India newspaper reports.

Is Asia's IP landscape in for big changes under TPP?

Selling the Trans-Pacific Partnership to a dozen nations after the details are out may prove something of a challenge, as an article in the Japan Times shows.

Regulators in Europe propose bans on plants in China and India

According to reports posted on the EudraGMDP site, regulators from Italy recommended bans on specific products made by Jinan Jinda Pharmaceutical in Shandong Province in China and Wuxi Jida Pharmaceutical in Jiangsu City, China, as well as Parabolic Drugs in Haryana, India.

Edwards ups TAVR guidance on Sapien 3 launch, looks to expand indication in 2016

Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.

Indian drugmaker in hot water with FDA over forged records

FDA investigators found a record-keeping mess at an Indian drug manufacturer that they say raises concerns about the quality of the active pharmaceutical ingredients that it shipped for use in U.S. drugs.

FDA clears devices to reduce snoring in patients without sleep apnea

InSleep Health just received FDA clearance for its Cloud9 Anti-Snoring System, which deploys continuous low positive airway pressure to help snorers (and their annoyed partners). The prescription-only device consists of an air-flow unit and headgear worn around the head that delivers oxygen into the nose. The two components are connected via a hose.

Pfizer drops effort to make Lipitor an OTC med

Millions of Americans take statins to help control their cholesterol and try to stay heart healthy. You just can't count on them to handle that on their own, Pfizer has found. And so the maker of Lipitor, the most successful statin of them all, has given up on its efforts to move the drug to an over-the-counter treatment.

Bio-Rad Labs grabs FDA approval for next-gen HIV test

Bio-Rad Laboratories snagged FDA approval for its next-generation HIV Ag-Ab test for early detection of the virus. The Hercules, CA-based company's BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 and HIV-2 markers in human blood samples, making it the first diagnostic approved by the agency that can differentiate the infections.